Kornimate/medical-research-clean huggingface dataset:
a study of the safety and tolerability of azd5213 effect on sleep for patients with alzheimer's/cognitive impairment

Conditions: Mild Cognitive Impairment; Mild Alzheimer's Disease

Summary: this is a study where azd5213 or placebo is given to patients with mild alzheimer's disease or mild cognitive impairment in a blinded and random assignment. the main study objective is to estimate the relationship of sleep duration versus dose after 4 weeks of treatment.

a phase iia safety and tolerability study to investigate the effect on sleep of 3 doses of azd5213 and placebo in patients with mild alzheimer's disease and mild cognitive impairment during 4 weeks of treatment, designed as a randomized, double-blind, multi-center, parallel group, placebo-controlled study

Eligibility criteria:
inclusion criteria: * patient and study partner to sign informed consent before initiation of any study-related procedures. * clinical diagnosis of alzheimers (ad) or mild cognitive impairment (mci) disease. * single caregiver for at least 6 months prior to screening, capable of accompanying the patient on clinic visits as needed. the caregiver must either be living with or visiting the patient at least 10 hours per week, split over multiple (at least 2) days, for the duration of the study. * single study partner, for at least several months prior to screening, capable of accompanying the patient on clinic visits as needed. the study partner must either be living with or visiting the patient at least 3 days per week for the duration of the study. * a body mass index (bmi=weight/height2) of 18 kg/m2 to 32 kg/m2. exclusion criteria: * significant neurological disease or dementia other than ad or mci. * current episode or symptoms of major depressive disorder or other major psychiatric disorder. * history of self-reported sleep duration of less than 4 hours per night or less than 4 hours average total sleep time per night during baseline psg assessment. * history or present symptoms of a sleeping disorder such as sleep apnea. * history of cancer in the last 5 years. * use of anti-ad drugs (including off-label drugs and herbal medications) with the exception of donepezil, memantine, and/or rivastigmine transdermal system, as monotherapy or in combination in the following conditions: treatment with donepezil (5 mg to 10 mg daily), memantine, and/or rivastigmine transdermal system or combination regimens for at least 3 months and a stable dose(s) for the last 2 months prior to randomization is allowed.

Keywords: mild cognitive impairment mild alzheimer's disease safety tolerability
postprandial hypotension and insulin levels

Conditions: Postprandial Hypotension; Hypoglycemia

Summary: the goal of this observational study is to learn about the relationship between postprandial hypotension and insulin levels in adults. the main question it aims to answer is: is the incidence of postprandial hypotension high in patients who undergo mixed meal test? is insulin level higher in individuals with postprandial hypotension compared to those without during a mixed meal test? patients with postprandial symptoms were scheduled for a mixed meal test, during which plasma glucose, insulin, c-peptide, blood pressure, and heart rate were measured at specific time points.


Eligibility criteria:
inclusion criteria: * adults with postprandial symptoms exclusion criteria: * individuals with prediabetes or diabetes, * those aged 65 and above, * patients using antihypertensive medications or with known hypertension, * those with active infections, * congestive heart failure, * peripheral artery disease, * advanced-stage dementia, * individuals who could not provide a history or were unable to cooperate, * patients using medications that could induce hypoglycemia (oral antidiabetics, insulin, beta-blockers, hydroxychloroquine, bromocriptine, etc.) * those with conditions that could cause hypoglycemia (uncontrolled hypothyroidism, adrenal insufficiency, growth hormone deficiency, etc.)

Keywords: hypotension hypoglycemia insulin mixed meal adults postprandial
impact of specific monitoring of intraoperative analgesia under general anesthesia on chronic pain after ovarian cancer surgery

Conditions: Ovarian Neoplasm

Summary: this is a single-center, randomized, phase ii, non-comparative, single-blind clinical study that will determine whether morphine reduction through intraoperative monitoring by ani (analgesia nociception index) significantly reduces chronic post-surgical pain at three months after laparotomy for ovarian carcinoma with regard to standard care.

prior to carrying out the research, the informed consent of the person must be obtained after being informed of the purpose of the research, its conduct and duration, benefits, potential risks and constraints of the study. before inclusion,all eligibility criteria will be verified, vas pain score and vas anxiety will be performed. the surgical procedure for ovarian carcinoma will be performed by laparotomy and the intraoperative monitoring of nociception wil depend of the randomization arm : intraoperative ani monitoring of nociception (experimental arm) versus no specific monitoring of nociception (control arm). the total dose of opioids (in micrograms) received by the patients will be recorded at the end of the surgery. vas pain score will be performed immediately postoperatively and at three months after the intervention. a dn4 questionnaire (neuropathic pain) will be evaluated at three months after the intervention.

Eligibility criteria:
inclusion criteria: 1. woman aged 18 years and over. 2. histologically proven or strongly suspected ovarian carcinoma. 3. indication for laparotomy surgery with xyphopubic incision. 4. acceptance of epidural anesthesia. 5. pain score ≤ 3 (vas or numeric verbal scale). 6. free and informed consent. 7. patient affiliated with a french social security scheme in accordance with french law on research involving human participants. exclusion criteria: 1. heart rhythm disturbances. 2. history of cerebral vascular accident (cva). 3. history of epilepsy. 4. wearing a pacemaker. 5. receiving morphine treatment preoperatively. 6. medical contraindication to an epidural. 7. patient unable to follow and adhere to trial procedures for geographic, social or psychological reasons. 8. patient placed under guardianship or curatorship. 9. patient already included in the present study.

Keywords: ovarian neoplasm analgesia monitoring pain measurement analgesia nociception index
effects of a self-management group-intervention on participation in post-stroke patients.

Conditions: Stroke

Summary: stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. literature shows that a stroke has a negative effect on participation. self-management (sm) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. the primary aim of this study is to assess the effectiveness of a group-based sm program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

at enrollment eligible patients will be randomized to intervention + standard care or standard care group. within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). the group-intervention (sm program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. the intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known sm interventions that were found effective for stroke patients in the u.s. standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). follow-up measures will be performed within a week after the end of the intervention, and 6 months thereafter, in order to examine long term effectiveness. outcome measures are questionnaires; change will be assessed by the difference in total score between t1 \|(pre-intervention), t2 (post-intervention) and t3 (after 6 months)

Eligibility criteria:
inclusion criteria: cerebrovascular accident diagnosed 3-18 months before enrollment. treated at th neurologic rehabilitation center of clalit health services in kiryat byalik, israel. living in the community (in their homes). are capable of basic communication in hebrew. exclusion criteria: moderate-severe stroke (national institutes of health stroke scale (nihss) score ≤ 16). moderate-severe cognitive impairment (montreal cognitive assessment (moca) - total score ≤ 16). inability to provide informed consent.

Keywords: self-management stroke intervention group processes
genetic study of amyotrophic lateral sclerosis in norway

Conditions: Amyotrophic Lateral Sclerosis

Summary: the purpose of this study is to explore the genetic causes relevant for als development in norway.

after being informed about the study and potential risks, all patients giving written informed consent will be asked to complete a small questionnaire regarding family history and have a blood sample withdrawn. blood samples, questionnaires, clinical information and signed consent is send to department of medical genetics, telemark hospital trust were the genetic analysis is performed successively throughout the recruitment period. patients can choose to have their genetic results returned in a diagnostic setting.

Eligibility criteria:
inclusion criteria: * probable or definite als * eligible to consent exclusion criteria: - not competent to give consent

Keywords: genetics amyotrophic lateral sclerosis neurology clinical genetics
repurposed use of allergic rhinitis and allergic asthma drug to reduce vertigo and hearing loss in meniere's disease

Conditions: Meniere Disease; Allergic Rhinitis; Vertigo

Summary: the purpose of this study is to evaluate a previously fda-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with meniere's disease.


Eligibility criteria:
inclusion criteria: * adults 18 years of age or older * must meet all aao-hns 2020 criteria for definite or probable meniere's disease * must have a skin test positive for allergy * is already a candidate for treatment with montelukast for allergic rhinitis/failed first line over-the-counter allergy treatments exclusion criteria: * had a previous surgical procedure for treatment of vertigo * currently receiving any allergy immunotherapy or taking montelukast or a beta-blocker * pregnant or recent pregnancy ((≤ 8 weeks postpartum), or lactation) * current hospitalization for any reason * any active, acute, or chronic pulmonary disorder other than asthma * history of intubation for asthma
immunotherapy with cd19 car t-cells for b-cell leukemia

Conditions: Leukemia

Summary: this study aims to evaluate the safety, efficacy and duration of response of cd19 chimeric antigen receptor (car) redirected autologous t-cells in patients with high risk, relapsed cd19+ haematological malignancies.

this is a multi-centre, non-randomised, open label phase i clinical trial of an advanced therapy investigational medicinal product named cd19 chimeric antigen receptor (car) t-cells (cd19 car t-cells) in patients with high risk, relapsed cd19+ leukemia. following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the cd19 car tcells. patients will receive the cd19car t-cells following lymphodepleting chemotherapy. the study will evaluate the safety, efficacy and duration of response of the cd19 car t-cells in patients with high risk relapsed cd19+ leukemia

Eligibility criteria:
inclusion criteria: 1. relapsed or refractory b cell leukemia. 2. kps\>60. 3. life expectancy\>3 months. 4. gender unlimited, age from 2 years to 70 years. 5. cd19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry. 6. patients who have failed at least one line of a standard treatment. 7. no serious mental disorder. 8. patients must have adequate cardiac function(no cardiac disease, lvef≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(cr≤133umol/l). 9. no other serious diseases(autoimmune disease, immunodeficiency etc.). 10. no other tumors. 11. patients volunteer to participate in the research. 12. patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active gvhd and no longer taking immunosuppressive agents for at least 30 days prior to trial exclusion criteria: 1. kps\<50. 2. patients are allergic to cytokines. 3. uncontrolled active infection. 4. acute or chronic gvhd. 5. treated with t cell inhibitor. 6. pregnancy and nursing females. 7. hiv/hbv/hcv infection. 8. other situations we think improper for the research.

Keywords: car-t leukemia
molecular genetic and pathological studies of anal tumors

Conditions: Rectal Cancer; Colon Cancer; Colonic Neoplasms; Anal Cancer

Summary: study the genetics of anal cancer

to determine the status of previously identified anal cancer molecular markers and any correlations with outcome as well as to discover new molecular biomarkers through correlating molecular data with clinical outcome. study of tissue samples and cells from biopsies of your lesion and blood sample. we hope to learn the role genes and proteins may play in the development of anal cancer. experiments will be performed using this tissue and blood, include analysis of dna, analysis of rna expression levels, analysis of protein levels of important gene products, and development of tissue culture cell lines.

Eligibility criteria:
inclusion criteria:inclusion criteria: * patients with anal tumors * undergoing surgery for elective colon and rectal surgery exclusion criteria:no other patients other than adult patients with anal cancer or high risk for anal cancer refered to stanford will be enrolled to the study. no children will be included to the study
safety and efficacy study of kl002 in the treatment of advanced primary pd

Conditions: Parkinson Disease

Summary: this is a non-randomized, open label, dose-escalation study to evaluate the safety and efficacy of kl002 in the treatment of advanced primary parkinson's disease. condition or disease: parkinson's disease intervention/treatment: drug: kl002 phase: na

9 patients will be enrolled to this open-label dose escalation study to evaluate up to three dose levels of kl002 of three patients each. all patients will receive bilateral intraputaminal injections of kl002 through stereotactic brain surgery. the safety and potential clinical responses to kl002 will be assessed by clinical evaluations of parkinson's disease, cognitive tests, laboratory blood tests and neuroimaging.

Eligibility criteria:
inclusion criteria: 1. males/females between 40 and 70 years (inclusive) 2. diagnosed with idiopathic parkinson's disease, hoehn and yahr stage 4 and 5 3. disease duration at least 5 years 4. mds updrs part iii (total motor) score ≥ 25 and a maximum of 60 in the off state 5. good compliance and can complete all follow-up in accordance with the protocol requirements exclusion criteria: 1. prior brain surgery including deep brain stimulation or abnormal brain imaging. 2. presence of depression as measured by hamilton depression scale ≥20 3. history of brain injury or central nervous system infection. 4. cognitive impairment score\<26 on moca and ≤ 20 on mmse dementia scale 5. evidence of significant medical or psychosis, such as dementia, psychosis, and a history of drug abuse 6. atypical or secondary parkinsonism, including but not limited to symptoms believed to be due to trauma, brain tumor, infection, cerebrovascular disease, other neurological disease, or to drugs, chemicals, or toxins. 7. prior gene therapy. 8. chronic immunosuppressive therapy, including chronic steroids, immunotherapy, cytotoxic therapy and chemotherapy 9. any other conditions that the investigator believed unsuitable for participation in this study.

Keywords: parkinson disease kl002 putamen stereotactic brain surgery
bootcamp during neoadjuvant chemotherapy for breast cancer

Conditions: Breast Cancer

Summary: this is a randomized, single-site pilot study incorporating one control group. this research involves an exercise group and a non-exercise group (control group). the patients who are in the exercise group will be enrolled in the dallas county women's adventure boot camp. this will require them to undergo exercise training 3 times per week, under the direction of an experienced personal trainer in a group setting. all boot camp personal trainers are trained in basic cardiac life support (cpr) and are trained to watch for any signs or symptoms associated with a poor exercise response. the investigators hypothesize that randomizing women to a supervised exercise program of core conditioning, muscular/circuit training, and short distance running administered during neoadjuvant chemotherapy for breast cancer can be performed. patients will continue on study as they are undergoing neoadjuvant chemotherapy for their breast cancer. this will be about 4 - 6 months.

the exercise protocol will consist of activities including walking/running up to a mile, calisthenics (jumping jacks, short relays, rapid punches) and light (no greater than 5 pounds) weight lifting. the patients who do not receive the exercise program will be allowed to do what they would normally do during their neoadjuvant chemotherapy. they are allowed to engage in their own exercise regimens and diet modifications. subjects will receive the chemotherapy as directed by their physicians, and then undergo surgery as planned. randomization will occur by drawing cards entitled "exercise" or "control" from an envelope and then assigning the patient to this group.

Eligibility criteria:
inclusion criteria: 1. receiving neoadjuvant chemotherapy for breast cancer at one of the ut southwestern hospitals or affiliates (simmons cancer center, parkland hospital) 2. no evidence of metastatic disease as confirmed by routine staging 3. 18 - 70 year old female 4. karnofsky score \>80% 5. body mass index \>25 kg/m2 6. able to speak, read and understand the english language 7. ability to understand and willingness to sign a written informed consent document 8. all races and ethnicities will be eligible. exclusion criteria: 1. unable to speak, read and understand the english language 2. patients may not be involved in other trials evaluating the efficacy of neoadjuvant therapy 3. insulin-dependent diabetic patients. 4. known to be pregnant or planning to become pregnant during the study. 5. subjects are prohibited from being on other cancer treatments aside from what their treating medical oncologist has prescribed, primarily additional chemotherapies.

Keywords: breast cancer neoadjuvant chemotherapy exercise ki-67
a bioequivalence study of 4 mg fesoterodine extended-release tablets (toviaz™) in healthy subjects

Conditions: Treatment of Overactive Bladder

Summary: to demonstrate bioequivalence of fesoterodine 4 mg tablets manufactured at vega baja, versus zwickau.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). exclusion criteria: * subjects with evidence or history of clinically significant urologic diseases * a positive urine drug screen * pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method

Keywords: bioequivalence
development of a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients respond to treatment with erlotinib. purpose: this laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

objectives: * assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ecog-e3503. * determine the loss of epithelial markers (e-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients. * assess whether mesenchymal and epithelial markers are predictive of progression-free survival (pfs) of these patients. * identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict pfs of these patients. outline: tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (snp) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (e-cadherin) marker transitions. after biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed. projected accrual: a total of 137 samples will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of non-small cell lung cancer, including any of the following subtypes: * adenocarcinoma * squamous cell carcinoma * bronchoalveolar carcinoma * carcinoid * stage iiib or iv or recurrent disease * must have received treatment with erlotinib hydrochloride on clinical trial ecog-e3503 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer bronchoalveolar cell lung cancer
study evaluating the efficacy and safety of etanercept

Conditions: Rheumatoid Arthritis

Summary: to assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active ra for whom classical antirheumatic therapy is insufficient or inappropriate.


Eligibility criteria:
inclusion criteria: * a negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide). * failed therapy with at least one dmard (dmard failure is defined as a discontinuation because of lack of clinical efficacy). * meet the 1987 american rheumatism association (ara) revised criteria for rheumatoid arthritis. exclusion criteria: * uncooperative patients with a history of poor compliance. * known hypersensitivity to etanercept or any of its components. * known significant concurrent medical disease
efficacy optimization research of telbivudine therapy

Conditions: Hepatitis B, Chronic

Summary: the purpose of this trial is to prove that the strategy of treatment adjustment at w24 according to virological response based on roadmap concept is better than standard of care strategy.


Eligibility criteria:
inclusion criteria: * male or female, from 18 (inclusive) to 65 (inclusive) years of age * hbsag and hbeag positive for over six months * patient is willing and able to comply with the study drug regimen and all other study requirements * patients must give written informed consent before any assessment is performed exclusion criteria: * detected m204i/v, n236t, a181v/t mutation in patient serum hbv dna at screening visit * patient has a history of or clinical signs/symptoms of hepatic decompensation * patient has a history of hepatocellular carcinoma (hcc) or findings suggestive of possible hcc * other protocol-defined inclusion/exclusion criteria may apply

Keywords: chronic hepatitis b